Trial Review

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT05180890




Registration number
NCT05180890
Ethics application status
Date submitted
3/01/2022
Date registered
6/01/2022
Date last updated
2/12/2022

Titles & IDs
Public title
A Study of Danavorexton (TAK-925) in Adults With Obstructive Sleep Apnea
Scientific title
A Phase 1b, Randomized, Double-Blind, Placebo-Controlled, 3-Period Crossover Study to Evaluate the Safety, Tolerability, Pharmacodynamic, and Pharmacokinetic Effects of Overnight Intravenous TAK-925 in Patients With Obstructive Sleep Apnea
Secondary ID [1] 0 0
TAK-925-1020
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Sleep Apnea 0 0
Condition category
Condition code
Respiratory 0 0 0 0
Sleep apnoea

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Danavorexton
Treatment: Drugs - Placebo

Placebo Comparator: Placebo - Placebo infusion, intravenously, administered overnight for approximately 10-hours on Days 1 to 2 in each Treatment Period 1, 2, or 3.

Experimental: Danavorexton LD - Danavorexton LD regimen, infusion, intravenously, administered overnight for approximately 10-hours on Days 1 to 2 in each Treatment Period 1, 2, or 3.

Experimental: Danavorexton HD - Danavorexton HD regimen, infusion, intravenously, administered overnight for approximately 10-hours on Days 1 to 2 in each Treatment Period 1, 2, or 3.


Treatment: Drugs: Danavorexton
Danavorexton intravenous infusion.

Treatment: Drugs: Placebo
Placebo intravenous infusion.
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Number of Participants With at Least one Treatment-emergent Adverse Event (TEAE)
Timepoint [1] 0 0
From the first dose of danavorexton in Treatment Period 1 up to approximately 7 days after the last dose of danavorexton in Treatment Period 3 (up to 41 days)
Secondary outcome [1] 0 0
Change From Baseline in Upper Airway Collapsibility Index (UACI)
Timepoint [1] 0 0
Baseline (-15 minutes from the start of infusion [first UACI]), and at 20 minutes (second UACI), and 55 minutes (third UACI) on Day 1 of each Treatment Period
Secondary outcome [2] 0 0
Apnea-Hypopnea Index (AHI) Observed During Overnight Polysomnographys (PSGs)
Timepoint [2] 0 0
Day 1 up to Day 2 of each Treatment Period

Eligibility
Key inclusion criteria
1. Has OSA diagnosed according to the International Classification of Sleep Disorders-3
(ICSD-3) criteria and an AHI of 12-50 events/hour sleep (documented by an in-clinic
PSG or at-home sleep test within the last 12 months). Participants who do not have PSG
results from within 12 months available may be offered a screening home sleep test.

2. Those who use continuous positive airway pressure (CPAP), oral appliance, or
hypoglossal nerve stimulator must be willing to forego this therapy during all
in-clinic PSGs and during the home sleep test if one is required.

3. Has no known history of a sleep disorder other than OSA based on interviews at the
screening visit, such as, for example, restless legs syndrome accompanied by periodic
leg movements of sleep.

4. Has a regular bedtime (example, between 8 p.m. - 1 a.m.) and regular time in bed
averaging between 6.0 and 10.0 hours/night, as verified by sleep tracking mat and
sleep diary data. Sleep durations and bedtimes outside of this range can be discussed
for inclusion on a case by case basis with the sponsor.

5. Has a body mass index (BMI) of 18 to 38.5 kilogram per square meter (kg/m^2)
inclusive.
Minimum age
18 Years
Maximum age
75 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Has an occupation requiring nighttime shift work or variable shift work within the
past 2 months or has travelled with significant jet lag within 14 days before the
study start or plans to travel with significant jet lag during the study.

2. Has nicotine dependence that is likely to have an effect on sleep (example, a
participant who routinely awakens at night to smoke) or challenge the conduct of this
study (smokes >=10 cigarettes/day), or the participant is unwilling to discontinue all
smoking and nicotine use during the confinement periods.

3. Has a caffeine consumption of more than 600 milligram (mg)/day for 7 days before
Period 1 Day 1 (1 serving of coffee is approximately equivalent to 120 mg of caffeine;
16 ounces of cola or energy drink contain approximately 39 and 148 mg of caffeine,
respectively).

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s

The people analysing the results/data
Intervention assignment
Crossover
Other design features
Phase
Phase 1
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
10/03/2022
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
23/11/2022
Sample size
Target
Accrual to date
Final
13
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
Adelaide Institute for Sleep Health (AISH), Flinders University - Adelaide
Recruitment postcode(s) [1] 0 0
5042 - Adelaide

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Takeda
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
The main aim of the study is to check the side effects from overnight treatment with
danavorexton and assess the tolerability of varying doses of danavorexton administered
intravenously.

Before starting treatment with danavorexton, participants will keep a sleep diary and use an
under-mattress sensor for at least 7 nights to check regular sleep habits.

There will be 3 Treatment Period up to 14 days apart. In each Treatment Period, participants
will receive an intravenous (through the vein) infusion of either danavorexton or a placebo
starting in the evening and continuing over a 10-hour period. A placebo looks exactly like
danavorexton but does not have any medicine in it.

Participants will take part in a follow-up phone appointment about a week after the last
Treatment Period.
Trial website
https://clinicaltrials.gov/ct2/show/NCT05180890
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Study Director
Address 0 0
Takeda
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT05180890